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PHILADELPHIA, Dec. 14, 2023 /PRNewswire/ — Carisma Therapeutics Inc. (Nasdaq: CARM) (“Carisma” or the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced the nomination of its first lead candidate under the collaboration with Moderna, Inc. (Nasdaq: MRNA). This first lead candidate will target an antigen present on a solid tumor with significant unmet medical need. This strategic collaboration brings together Carisma’s chimeric antigen receptor macrophage (CAR-M) platform with Moderna’s messenger RNA (mRNA) and lipid nanoparticle (LNP) technologies to generate and develop in vivo CAR-M therapeutics for oncology.

“Following the compelling pre-clinical proof of concept data shared at SITC 2023, we believe in vivo CAR-M therapeutics that utilize Moderna’s mRNA/LNPs have the potential to benefit patients with a broad variety of cancers,” stated Michael Klichinsky, PharmD, PhD, Co-Founder and Chief Scientific Officer at Carisma. “The delivery of this first candidate demonstrates our ability to create novel in vivo CAR therapies that can be advanced toward the clinic. We are proud of the significant contributions made by both of the scientific teams at Carisma and Moderna towards this exciting program. We look forward to completing IND-enabling studies with the lead candidate and are excited about the prospect of bringing this therapy forward for patients with advanced solid tumors together with Moderna.”

Lin Guey, PhD, Chief Scientific Officer of Therapeutics Research Ventures and Biotherapeutics at Moderna, stated, “We are excited with the progress we’ve made to advance in vivo cell therapy (CAR-M) in collaboration with Carisma. Combining Carisma’s deep expertise in myeloid cell biology with our mRNA/LNP platform has allowed us to quickly advance the first lead candidate and we look forward to furthering its development, along with our continued collaboration with Carisma to develop novel therapies to treat patients.”

Pre-clinical proof of concept data were recently presented at SITC 2023, demonstrating the feasibility, efficacy, and tolerability of the in vivo CAR-M platform that utilizes Moderna’s optimized mRNA encapsulated in LNPs and is designed to redirect endogenous myeloid cells to exert targeted anti-tumor activity. The highlighted data demonstrated that Carisma’s CAR-M therapy can be directly produced in vivo, or within the body, and can successfully redirect endogenous myeloid cells against tumor-associated antigens using Moderna’ mRNA/LNPs. This novel approach to cancer immunotherapy offers an off-the-shelf solution that has the potential to increase access to CAR-based therapies and to be the basis of any CAR-M programs discovered or developed under the Carisma and Moderna collaboration.

Successful primary and secondary results demonstrate proof of feasibility in male patients, paving way for launch of large-scale pivotal clinical study in the U.S. and Europe

GRENOBLE, France and MINNEAPOLIS, Dec. 13, 2023 /PRNewswire/ — UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today it has reached a significant milestone: the complete treatment cohort in the first-of-its-kind clinical feasibility study has successfully reached the six-month primary endpoints.

The feasibility assessment of the UroActive System was completed through a prospective multicenter clinical study. UroActive is the first smart automated artificial urinary sphincter (AUS) to treat SUI, and the only one to reach this critical milestone. The results of this initial clinical study support design and implementation of UroMems’ pivotal SUI trial in Europe and the U.S. All six men are now implanted for at least seven months and up to fifteen months, with their devices operating as expected and no need for revision nor explant. In addition, extremely positive follow-up was received on secondary outcomes measures, including leak rate values and patient quality of life questionnaires.

UroMems received very positive feedback from all patients participating in the study cohort. “You have changed my life,” stated one of the study participants. “I can do all activities again, without stress, without anxiety!”

“We’re so pleased to see that our expectations about our device’s performance were met or even exceeded and delighted to successfully treat and receive such high praise from patients who had been suffering from SUI for years,” said Professor Pierre Mozer, UroMems chief medical officer and co-founder. “The results of this study will allow us to prepare our pivotal study which will be a major step in the development of UroActive.”

UroActive is the first smart active implant that treats SUI, powered by a MyoElectroMechanical System (MEMS). This innovative system is placed around the urethral duct and is controlled based on the patient’s activity, without the need for manual adjustments, intending to provide patients with ease of use and a better quality of life than current options.

“The very compelling results of this first-in-man clinical study demonstrate the high potential of our technology and pave the way for larger clinical trials that will allow us to demonstrate all the benefits we are expecting to offer patients suffering from debilitating SUI,” said Hamid Lamraoui, UroMems chief executive officer and co-founder. “We could not have reached this important milestone without the enthusiastic participation of the men in this initial study cohort. We’re extremely grateful to them for being a vital part in bringing this potentially revolutionary treatment to market.”

SUI, or involuntary urinary leakage, affects an estimated 40 million Americans and 90 million Europeans, and occurs when the pressure in the bladder exceeds that of the muscle (the sphincter) around the urethra, caused by activities involving high intra-abdominal pressure, like coughing, laughing and exercising. SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low self-esteem and social stigma.

EINDHOVEN, the Netherlands — November 06, 2023 — ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces a publication in Nature Medicine using investigational ONWARD ARC Therapy to address gait challenges related to Parkinson’s disease.

The study participant described in the Nature Medicine publication has been living with Parkinson’s disease for nearly three decades. He has a severe gait disorder that has not responded to conventional therapies.

“I could hardly walk without frequent falls, several times a day. In certain situations, like getting into an elevator, I would stomp, freeze as they say,” said the study participant in a press release issued by Switzerland’s Lausanne University Hospital (CHUV).

In 2021, researchers from the Swiss Federal Institute of Technology (EPFL) and CHUV investigated the possibility that ONWARD ARC Therapy (precise, targeted electrical stimulation of the spinal cord) could address common side effects of Parkinson’s disease that negatively impact mobility. The team collaborated with Dr. Erwan Bezard, a renowned neuroscientist from France’s National Institute of Health and Medical Research (INSERM).

After the introduction of ARC Therapy and benefitting from a few weeks of rehabilitation, the study participant was able to walk without previously noticeable gait interruptions. Today, he uses ARC Therapy eight hours per day.

“I turn on the stimulation in the morning and turn it off in the evening. It allows me to walk better, to stabilize myself. Even stairs don’t scare me anymore. Every Sunday I go to the lake, and I walk about six kilometers. It’s awesome,” said the participant in the CHUV release.

“The breakthrough reported in Nature Medicine shows the remarkable potential to use the same technology platform and therapy we are developing for spinal cord injury to also address mobilitychallenges stemming from Parkinson’s disease,” says Dave Marver, CEO of ONWARD.

“It is impressive to see that by electrically stimulating the spinal cord the same way we have done in paraplegic patients, we may be able to address gait disorders due to Parkinson’s disease,” adds neurosurgeon Jocelyne Bloch, co-director with Professor G. Courtine of ONWARD research partner .NeuroRestore.

.NeuroRestore was awarded a $1 million grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to implant the ARC-IM System and investigate the effect of ARC Therapy in six additional participants with Parkinson’s disease. This study will assist ONWARD in determining whether to conduct additional clinical trials and potentially commercialize ARC Therapy in the future for those living with Parkinson’s disease.

“MJFF is committed to fulfilling the unmet needs of people living with Parkinson’s disease by ensuring the development of improved therapies,” said Katharina Klapper, Director of Clinical Research, MJFF. “The Foundation is pleased to award a grant for scientists at EPFL and ONWARD Medical to investigate the effects of ARC Therapy in people with experiencing gait challenges.”

All ONWARD devices and therapies, including but not limited to ARC-IM, ARC-EX, and ARC Therapy, are investigational and not available for commercial use.

Note: ONWARD has previously disclosed achievement of human proof-of-concept for Parkinson’s disease in its Company Presentation.

PHILADELPHIA, Oct. 31, 2023 /PRNewswire/ — Carisma Therapeutics Inc. (Nasdaq: CARM) (“Carisma” or the “Company”), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced that it will present new findings at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting regarding its first-of-its-kind collaboration with Moderna. The collaboration aims to bring together Carisma’s chimeric antigen receptor macrophage (CAR-M) platform with Moderna’s mRNA and lipid nanoparticle (LNP) technologies to generate and develop in vivo CAR-M therapeutics.

Accepted as a late-breaking presentation, “In vivo CAR-M: Redirecting endogenous myeloid cells with mRNA for cancer immunotherapy,” showcases data that demonstrate Carisma’s CAR-M therapy can be directly produced in vivo, or within the body, successfully redirecting endogenous myeloid cells against tumor-associated antigens using mRNA/LNP. The pre-clinical data demonstrate feasibility, tolerability, and efficacy against metastatic solid tumors. This novel approach to cancer immunotherapy offers an off-the-shelf solution that has the potential to increase access to CAR-based therapies and will be the basis of CAR-M programs to be developed under the Carisma and Moderna collaboration.

“The data presented at SITC is incredibly exciting as it demonstrates that we have the ability to make CAR-M directly in vivo with mRNA/LNP technology, leading to robust and targeted anti-tumor activity,” said Michael Klichinsky, PharmD, PhD, Co-Founder and Chief Scientific Officer at Carisma. “This off-the-shelf approach to treat cancer with engineered myeloid cells, developed in collaboration with Moderna, has the potential to transform the CAR field and be applied to numerous cancer targets and indications.”

“We are pleased to share data about the successful application of our mRNA platform to advance in vivo cell therapy,” said Lin Guey, PhD, Chief Scientific Officer of External Research Ventures at Moderna. “We look forward to the continuation of our pre-clinical work with Carisma and are optimistic that the joint scientific knowledge of both companies will accelerate the development of novel in vivo CAR-M therapies for patients.”

Details of Carisma data accepted for presentation at the SITC 38th Annual Meeting are as follows:

• “In vivo CAR-M: Redirecting endogenous myeloid cells with mRNA for cancer immunotherapy” presented on Friday, November 3, 2023, at 11:30 am PT
• “CAR-Macrophages with custom intronic shRNA exhibit enhanced efficacy against solid tumors” presented on Friday, November 3, 2023, 9:00 am – 7:00 pm PT
• “Engineered Microenvironment Converters (EM-C): Macrophages expressing synthetic cytokine receptors reverse immunosuppressive signals in solid tumors” presented on Friday, November 3, 2023, 9:00 am – 7:00 pm PT
• “A Phase 1, First in Human (FIH) study of autologous macrophages engineered to express an anti-HER2 chimeric antigen receptor (CAR) in participants (pts) with HER2 overexpressing solid tumors” presented on Friday, November 3, 2023, 9:00 am – 7:00 pm PT

Presentation and posters will be available on the SITC 38th Annual Meeting portal for registered attendees.

PHILADELPHIA, Oct. 25, 2023 /PRNewswire/ — Carisma Therapeutics Inc. (Nasdaq: CARM) (“Carisma” or the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced that new pre-clinical data leveraging an mRNA platform to develop in-vivo chimeric antigen receptor macrophage (“CAR-M”) will be presented as a late-breaking abstract (#LBA1514) at the upcoming Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting held from Wednesday, November 1, to Sunday, November 5, 2023, in San Diego, California. Two posters highlighting next-generation enhancements to Carisma’s CAR-M platform, including a custom intronic shRNA approach and data on Engineered Microenvironment Converters (EM-C), will also be presented. Additionally, Carisma will share a trial-in-progress poster overviewing its Phase 1 first-in-human (FIH) study design of its lead program, CT-0508, sharing objectives and eligibility criteria.

Carisma will participate in the virtual SITC 2023 Annual Meeting Press Conference on Wednesday, November 1, 2023, from 12:00–1:30 pm PT.

“We are excited to present this pre-clinical data from our collaboration with Moderna for the first time,” said Steven Kelly, President and Chief Executive Officer of Carisma. “Over the past year, we have leveraged the expertise of both companies to pioneer the development of in-vivo mRNA/LNP-based cell therapy. The study is exploring the potential for an off-the-shelf treatment approach to enhance therapeutic benefit for patients living with cancer.”

Oral & Poster Presentations:

• In vivo CAR-M: Redirecting endogenous myeloid cells with mRNA for cancer immunotherapy
  • Primary Author: Bindu Varghese, PhD
  • Presentation Type/#: Oral – 1514
  • Session Date/Time (PT): Friday, November 3, 2023, 11:30 am, Session 104: Late Breaking Abstract Session
• CAR-Macrophages with custom intronic shRNA exhibit enhanced efficacy against solid tumors
  • Primary Author: Chris Sloas, PhD
  • Presentation Type/#: Poster – 307
  • Session Date/Time: Friday, November 3, 2023, 9:00 am – 7:00 pm
• Engineered Microenvironment Converters (EM-C): Macrophages expressing synthetic cytokine receptors reverse immunosuppressive signals in solid tumors
  • Primary Author: Chris Sloas, PhD
  • Presentation Type/#: Poster – 389
  • Session Date/Time: Friday, November 3, 2023, 9:00 am – 7:00 pm
• A Phase 1, First in Human (FIH) study of autologous macrophages engineered to express an anti-HER2 chimeric antigen receptor (CAR) in participants (pts) with HER2 overexpressing solid tumors
  • Primary Author: Kim Reiss, MD
  • Presentation Type/#: Poster – 635
  • Session Date/Time: Friday, November 3, 2023, 9:00 am – 7:00 pm

Presentation and posters will be available in the Journal for ImmunoTherapy of Cancer (JITC) supplement once published on Tuesday, October 31, 2023, at 9:00 am ET.

Houston, Texas and Tuebingen, Germany, October 24, 2023 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced that its IMA203 TCR-T program has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA Center for Biologics Evaluation and Research (CBER) in multiple relapsed and/or refractory HLA-A*02:01-positive and PRAME-expressing cancers, including cutaneous melanoma, uveal melanoma, endometrial carcinoma, synovial sarcoma, and ovarian cancer. IMA203 is a TCR-T cell therapy targeting PRAME, a protein frequently expressed in a large variety of solid tumors.

“The FDA RMAT designation for multiple indications underscores the broad potential of IMA203 and the benefits it may provide for advanced-stage solid tumor patients. This is an important regulatory milestone and a recognition of our clinical development progress for this program,” said Cedrik Britten, Chief Medical Officer of Immatics. “The close support from the FDA resulting from the RMAT status enhances our efforts to accelerate bringing IMA203 to cancer patients by enabling real-time discussions on patient populations, trial design and CMC.”

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation programs. An investigational cell therapy is eligible for RMAT designation if it meets the definition of regenerative medicine therapy, it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with the FDA that may be used to discuss potential surrogate or intermediate endpoints for accelerated approval and potential ways to satisfy post-approval requirements, potential priority review of the biologics license application (BLA) and other opportunities to expedite development and review.

Based on publicly available information¹, it is the Company’s understanding that this is the first time that FDA has granted a RMAT designation for an oncology drug candidate for more than two solid tumor indications. As of Sep 30, 2023, the U.S. FDA has received at least 238 requests for RMAT designations and granted 92².

About IMA203 and target PRAME
ACTengine® IMA203 T cells are directed against an HLA-A*02:01-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers, thereby supporting the program’s potential to address a broad cancer patient population. Immatics’ PRAME peptide is present at a high copy number per tumor cell and is homogeneously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform, XPRESIDENT®. Through its proprietary TCR discovery and engineering platform XCEPTOR®, Immatics has generated a highly specific T cell receptor (TCR) against this target for its TCR-based cell therapy approach, ACTengine® IMA203.

ACTengine® IMA203 TCR-T is currently being evaluated in three ongoing Phase 1b dose expansion cohorts in last-line patients: Cohort A IMA203 GEN1 monotherapy, Cohort B IMA203 in combination with an immune checkpoint inhibitor (deprioritized) and Cohort C IMA203CD8 GEN2 monotherapy, where IMA203 engineered T cells are co-transduced with a CD8αβ co-receptor.

About ACTengine®
ACTengine® is a personalized cell therapy approach for patients with advanced solid tumors. The patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor. The approach is also known as TCR-engineered cell therapy (TCR-T). All Immatics’ ACTengine® product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.

The ACTengine® T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth.

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Las Vegas, October 10, 2023 – Sidekick Health, a global leader in digital health innovation, is poised to transform the landscape of digital therapeutics with the strategic acquisition of aidhere, a leading developer of prescription digital therapeutics (PDT) based in Germany.

In a significant move that underscores Sidekick Health’s commitment to furthering the impact of digital healthcare, the company is thrilled to announce its expansion into the direct prescribing space working collaboratively with healthcare providers.

This acquisition brings with it zanadio, one of the most successful PDTs launched to date. zanadio has fulfilled over 50,000 prescriptions and is recognized within Germany’s regulated  nationwide DiGA (Digitale Gesundheitsanwendungen) formulary for prescribable digital apps. Achieving long-term behavioral change and significant weight loss of 8% in patients at the end of 12 months^[1], and with over 10,000 doctors prescribing it, zanadio is fully reimbursed for patients with a BMI from 30 to 40 kg/m². As a permanently approved DiGA, zanadio is reimbursed by all statutory health insurers in Germany.

Sidekick Health’s CEO, Dr. Tryggvi Thorgeirsson, shared that the decision to acquire aidhere was fueled by the shared PDT vision and cultural alignment of the two organizations. “Developing and distributing prescribed therapeutics has always been core to our long-term vision, and when we were introduced to aidhere’s remarkable products and exceptional team, we knew that joining forces was the right step to take,” said Thorgeirsson.

This strategic acquisition places Sidekick Health at the forefront of the industry, while presenting exciting opportunities for the introduction of a new offering to Payer partners in the US, and the co-development of prescription digital therapeutic products with global pharmaceutical partners.

By integrating aidhere’s expertise and products into its portfolio, Sidekick Health strengthens its position as a trusted partner for global health insurers and pharmaceutical giants as it pioneers the introduction of PDTs.

In addition to the newly formed PDT business, Sidekick Health’s business is primarily centered on two areas: payers in the US and global pharma. Within the US payer landscape, the company has notably collaborated with the largest US health insurer, and is live with US insurance partners in Medicare, Medicaid and commercial populations. In the pharmaceutical sector, it has cultivated strategic partnerships with industry giants like Pfizer and Eli Lilly, with multiple live programs in both the US and Europe, and expanding to more markets in 2024.

The acquisition brings together the passion, knowledge, and experience of two industry leaders. Sidekick Health’s robust digital health ecosystem, a patient-centric platform with multi-chronic capabilities that supports over 20 disease areas, coupled with aidhere’s expertise in highly-regulated PDTs, creates a synergy poised to redefine patient-centric care. With its platform approach, Sidekick Health is positioned to emerge as a natural consolidator in the digital therapeutics space.

“aidhere has a strong and respected track record within the digital health industry, with one of the most successful PDT products in the world. This acquisition brings market-leading products and a depth of expertise in prescription digital therapeutics to Sidekick, as we enhance and build on our patient care offerings in the digital health and therapeutics space with our global partners,” said Thorgeirsson.

Sidekick Health’s recent success in closing its Series B fundraising round in May 2022 laid the foundations for the company to accelerate innovation and drive even greater impact in the digital health and therapeutics sector. Notable investors in Sidekick Health include Novator Partners, Asabys Partners, Frumtak Ventures, and Wellington Partners.

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Cambridge, Mass. (Oct 11, 2023) – eGenesis, a biotechnology company developing human-compatible (HuCo™) organs for the treatment of organ failure, today announced publication in the journal Nature of long-term survival data from a proof-of-concept study evaluating engineered porcine donor kidneys transplanted into a cynomolgus macaque model. This dataset will support advancement of the company’s lead candidate for kidney transplant,
EGEN-2784, toward clinical development.

These results represent the largest and most comprehensive preclinical dataset published in the field to date. Recipient survival in the preclinical setting has historically been measured in weeks or months. The publication titled: “Design and Testing of a Humanized Porcine Donor for
Xenotransplantation,” reported long-term survival of NHP recipients of the company’s genetically engineered porcine kidneys. In the case of one recipient, survival of over two years (758 days) was achieved.

“At eGenesis, we are focused on transformational progress for the field – improving long-term survival for transplant recipients from months to years,” said Michael Curtis, Ph.D., Chief Executive Officer of eGenesis. “Our HuCoTM organs offer the hope of a new donor source for the hundreds of thousands of individuals in need of lifesaving organ transplants. The data published in Nature illustrate our rapid advancement in engineering porcine donor organs to enhance recipient compatibility and long-term survival, a critical step toward successful translation in human clinical trials.”

The donor kidneys evaluated in this study carried three types of edits: (1) knock out of three genes involved in the synthesis of glycan antigens implicated in hyperacute rejection, (2) insertion of seven human transgenes involved in the regulation of several pathways that modulate rejection: inflammation, innate immunity, coagulation, and complement, and (3) inactivation of the endogenous retroviruses in the porcine genome.

Donor kidneys carrying human transgenes resulted in longer survival time when transplanted into NHPs. Donor kidneys containing only knock out of the three-glycan antigens experienced poor graft survival, whereas those harboring the knock outs and human transgenes resulted in more than seven times longer duration – a median of 24 days versus 176 days, respectively. The results indicate the benefit of human transgene expression in porcine kidney grafts onlong-term survival.

In vitro functional analysis showed that edited porcine kidney endothelial cells modulated inflammation in a manner that mirrored human endothelial cells, suggesting the edited cells acquired a high level of human immune compatibility. Furthermore, the evaluation of renal function biomarkers in recipients with stable grafts revealed that a single transplanted porcine kidney provided sufficient filtration of metabolites to compensate for the lack of two native kidneys.

“This is a major step forward for the field of transplantation,” said Tatsuo Kawai, M.D., Ph.D., Professor of Surgery at Harvard Medical School and A. Benedict Cosimi Chair in Transplant Surgery at Massachusetts General Hospital. “One of the biggest hurdles has been long-term survival of the genetically engineered organ in the NHP recipient, and this dataset demonstrates remarkable progress in editing the porcine genome to minimize hyperacute rejection, improve recipient compatibility and address the risk of viral transmission from donor to host. We anticipate that transplant outcomes in humans will be even more favorable, as these gene edited organs are a better match for humans, as compared with NHPs.”

The data generated in this study will support the advancement of the company’s lead candidate for kidney transplant, EGEN-2784, toward clinical development. eGenesis is also progressing programs for extracorporeal liver perfusion as well as cardiac transplant.

Organ failure is a life-threatening condition for which transplantation is considered the gold standard treatment. However, the demand for organs far outstrips supply – of the more than 100,000 individuals on the organ transplantation waitlist in the U.S., less than 40% will receive a potentially life-saving organ. In addition, the existing organ failure treatment paradigm is suboptimal for patients and the healthcare system due to organ incompatibility and variable donor organ quality.

Planegg-Martinsried, Germany, 25 September 2023 – 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage CTCL, today announces that renowned dermato-oncology expert and study investigator, Professor Dr. Rudolf Stadler, University Hospital Johannes Wesling, Minden, Germany, presented positive new data from the pivotal RESMAN study of resminostat (Kinselby) at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting, at the Leiden University Medical Center Amsterdam, The Netherlands, 21-23 September.

The presented findings show that maintenance therapy is now clinically proven to postpone disease progression in advanced CTCL which could significantly change clinical practice. In RESMAIN, one of the largest randomized, controlled clinical trials in advanced CTCL, resminostat (Kinselby) treatment has shown a statistically significant improvement in progression free survival of 97.6% compared to placebo, with a risk reduction of 38% in recently announced headline trial results (median PFS: 8.3 months versus 4.2 months; p=0.015; HR: 0.623 (95%CI: 0.424, 0.916).

Furthermore, resminostat (Kinselby)’s median time to next treatment (median TTNT) versus placebo showed a significant improvement of 8.8 months compared to 4.2 months; p= 0.002; HR: 0.594 (95% CI: 0.424, 0.916).

The side effects of resminostat were mainly mild to moderate, manageable and reversible and the known safety profile of resminostat (Kinselby) was confirmed in the RESMAIN study.

Additional analyses established that those treated showed a clinically meaningful improvement in median “total” PFS (defined from start of last prior therapy to disease progression) of 24.3 months, compared to 14.9 months for those in the placebo group. It was also noted that there was a significant delay in the development of new, or worsening of existing, skin tumours.

Jason Loveridge, Ph.D., CEO of 4SC, commented: “Positive data from the RESMAIN study demonstrate that resminostat (Kinselby) is effective in significantly slowing disease progression in CTCL patients. This unique treatment, which is the only proven maintenance therapy for CTCL, means that it is well placed to offer significant benefits for patients who would otherwise have no other similar treatment options available to them. 

Our focus in the near term is on the registration, approval and commercialization of Kinselby in the European Union, Switzerland and the UK and we are on track to file for European Marketing Approval of Kinselby in Q1 2024, to rapidly bring this therapy into clinical use. 4SC is well positioned for realization of resminostat (Kinselby)’s considerable value through either a sale, licensing, or partnership agreement.”

The Company will host a live webinar on Wednesday 4th October to discuss the findings presented at EORTC. Dr. Susanne Danhauser-Riedl, 4SC’s Chief Medical Officer, will be joined by medical experts, Professor Dr. Rudolf Stadler and Professor Julia Scarisbrick, who will provide further detail on these data, with the presentation being followed by the opportunity to ask questions during a Q&A session moderated by Dr. Jason Loveridge, 4SC’s Chief Executive Officer.

Title: Presentation by Professor Rudolf Stadler and Professor Julia Scarisbrick on recent new positive data from the RESMAIN study

Date and Time: Wednesday 4^th October, 3.00pm CET

Register and submit questions: https://stream.brrmedia.co.uk/broadcast/64f5f2dac6e9d7476c27f154

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